Label: TESTOSTERONE- testosterone, tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 29, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT:

    Testosterone 30X.

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  • INDICATIONS:

    May help increase lean muscle mass and sexual libido, also may help decrease symptoms of fatigue.

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  • WARNINGS:

    Not intended for persons under the age of 18. 

    If pregnant or breast-feeding, do not use.

    Consult a health professional prior to use if you have any pre-existing medical conditions or take any prescription medications.

    Do not consume with any caffeine or stimulants.  Improper use will not improve results and is potentially hazardous to a person's health.

    Use only as directed.

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poision Control Center right away.

    Do not use if tamper evident seal is broken or missing.

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  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

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  • DIRECTIONS:

    Adults take 1-2 tablets daily.  Read warnings and use only as directed.

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  • INDICATIONS:

    May help increase lean muscle mass and sexual libido, also may help decrease symptoms of fatigue.

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  • INACTIVE INGREDIENTS:

    Microcrystaline cellulose, Magnesium stearate, Croscarmellose sodium, Silicon dioxide, Stearic acid.

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  • QUESTIONS:

    Developed and manufactured for:

    Zoe Processing

    P.O. Box 487

    Avon, OH 44011

    WWW.TESTOSTERONERX.COM

    To report a serious adverse event or obtain product information, please cal 1-866-607-2768.

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  • PACKAGE LABEL DISPLAY:

    Testosterone Tablets

    Homeopathic

    50 tablets

    Testosterone Tablets

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  • INGREDIENTS AND APPEARANCE
    TESTOSTERONE 
    testosterone, tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:44117-0002
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE 30 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    CREATINE MONOHYDRATE (UNII: 9603LN7R2Q)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score no score
    Shape capsule (LARGE CAPLET TABLET) Size 22mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44117-0002-1 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/29/2014
    Labeler - Zoe Processing (040866348)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(44117-0002) , api manufacture(44117-0002) , label(44117-0002) , pack(44117-0002)
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